Vapotherm, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HVT 2.0, HVT 2.0, Vapotherm Aerosol Adapter AAA-2
13
Total
12
Cleared
1
Denied
FDA 510(k) Regulatory Record - Vapotherm, Inc. Anesthesiology ✕
13 devices
Cleared
Apr 13, 2026
HVT 2.0
Anesthesiology
116d
Cleared
Dec 13, 2022
HVT 2.0
Anesthesiology
221d
Cleared
Oct 28, 2022
Vapotherm Aerosol Adapter AAA-2
Anesthesiology
217d
Cleared
Aug 25, 2021
HVT 2.0
Anesthesiology
282d
Cleared
Oct 10, 2019
Palladium High Flow Therapy System
Anesthesiology
177d
Not Cleared
Apr 10, 2018
Precision Flow® HVNI
Anesthesiology
462d
Cleared
Oct 07, 2011
PRECISION FLOW(R) - HELIOX
Anesthesiology
116d
Cleared
Feb 08, 2011
FLOWREST
Anesthesiology
90d
Cleared
Jul 17, 2008
PRECISION FLOW
Anesthesiology
287d
Cleared
Apr 13, 2007
VAPOTHERM MODEL# 2000I AND 2000H
Anesthesiology
98d
Cleared
Aug 30, 2004
VAPOTHERM MODEL#2000I, 200H
Anesthesiology
11d
Cleared
May 30, 2003
VAPOTHERM 2000H
Anesthesiology
588d
Cleared
Aug 24, 2000
VAPOTHERM, MODEL 2000I
Anesthesiology
199d